Bharat Biotech's Partner Says Covaxin Shows Positive Results In Phase 2/3 Study In U.S.
"The successful completion of this study represents an important milestone to the ongoing management of Covid-19," Musunuri said.
Ocugen Inc., Bharat Biotech's partner for U.S. and Canada for Covid-19 vaccine Covaxin (BBV152) on Monday said it got positive results from the Phase 2/3, observer-blind, immuno-bridging and broadening study of the jab in U.S.
A press release from the U.S. biopharmaceutical company said the study enrolled 419 U.S. adult participants that were randomised 1:1 to receive two doses of Covaxin or placebo, 28 days apart.
"The successful completion of this study represents an important milestone to the ongoing management of Covid-19. Given that a portion of the public remains hesitant to receive mRNA vaccines, this investigational Covid-19 vaccine candidate, which relies on a well-established approach to vaccine development and manufacturing, may provide an important additional vaccine option," Shankar Musunuri, chairman and CEO of Ocugen said.
Immunogenicity results from Covaxin-vaccinated participants in the U.S. were compared with results in Covaxin-vaccinated participants in the Bharat Biotech-sponsored Phase 3 study in India.
Approximately 24% of tested participants in U.S. were vaccine-naive, while all participants in the Bharat Biotech Phase 3 study were vaccine-naïve, it said.
The top-line data from the immuno-bridging and broadening study will be critical to support Ocugen’s future plans for the development of Covaxin in U.S., the release said.